Medical Reviewer

2 days ago

Bengaluru Karnataka, India Navitas Life Sciences Full time

Job Description

We are currently seeking a Senior Clinical Research Associate to join our growing team. The role will include the following:

- Responsible for Medical Review activities
- Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous, and solicited reports
- Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
- Perform triage of cases and determine seriousness and relatedness across products as assigned
- Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative
- Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
- Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
- Conduct assessment of litigation cases across products as assigned
- Identify and resolve case issues, co-ordinate with client therapeutic teams/site for specific products or functional groups
- Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
- Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and tracking and evaluating potential issues
- Perform literature review activities and provide medical judgements for ICSRs, aggregate safety reports, Signal reports and RMP
- Prepare and medical review of periodic aggregate safety reports, Signal reports and RMP
- Support the preparation and maintenance of safety sections of the Company Core Data Sheet
- Resolution of site level issues and where necessary escalation of issues to PM
- Lead/support PDS post-marketing safety study activities
- Carry out signal detection activities and evaluation
- High level of proficiency of all workflow tasks.
- To work independently but guided by documented procedures, with appropriate support.
- Following up with sites regarding outstanding queries.
- Follow up on reconciliation of discrepancies.
- Mentor and guide the activities of Junior Medical Reviewers.
- Desirable Skills and Experience
- Good understanding of medical matters
- Good knowledge of GCP and pharmacovigilance principles and related guidelines and regulations
- Basic competence with medical and therapeutic terminology
- Understanding of patient safety regulatory obligations
- Should be familiar with regulatory and pharmacovigilance guidelines
- Good command of written and spoken English; additional languages favourable
- Good knowledge of usual office software (MS Office: Word, Excel, PowerPoint)
- Experience in database handling, data entry (e.g. ARGUS, ArisG)
- Soft skills (motivation, strong communication competence, structured in work, organising skills, reliability, commitment and capacity for team-work)

**Bangalore, India**

**MBBS or MD; completed a board certification and/or relevant higher medical training**

**Associate**

**Pharmacovigilance and Safety**

**Full Time

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